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Impact of Endotest on Patients' Quality of Life: a Cohort Study (ENDOLIFE)

20. maj 2026 opdateret af: ZIWIG

Ziwig Endotest® ('Endotest') is marketed in several countries, including Switzerland, which was the first country to make it available in 2022. Since February 2025, several French clinical investigation sites have been offering Endotest, developed by Ziwig, under the innovation funding. Initially, this innovation funding enabled 2,500 patients to be included in a clinical trial (ENDOBEST: ID-RCB 2024-A02092-45). Since the end of December 2025, it has been expanded and now covers a further 22,500 patients whose are not included in the trial. This medical device is based on Next-Generation Sequencing combined with analytical algorithms and enables the identification of endometriosis from a saliva sample. This non-invasive test aims to improve patient care by reducing diagnostic delays and guiding treatment strategies.

Despite the available data on its diagnostic performance, the impact of Endotest on patients' quality of life, their emotional experience, their coping strategies, and their care pathways remains insufficiently documented. Indeed, the Endotest result (positive or negative) can significantly influence these various aspects. This cohort study aims to assess the impact of Endotest on patients' quality of life, primarily using validated self-report questionnaires and clinical data from medical records. By including a large sample of patients, this study aims to provide robust and generalisable data that will be useful for clinicians and patients themselves.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
    • Gironde
      • Bordeaux, Gironde, Frankrig, 33000
        • Rekruttering
        • Clinique Tivoli Ducos
        • Kontakt:
    • Ille-et-Vilaine
      • Saint-Grégoire, Ille-et-Vilaine, Frankrig, 35760
        • Ikke rekrutterer endnu
        • Hôpital privé Saint-Grégoire
        • Kontakt:
    • Morbihan
      • Lorient, Morbihan, Frankrig, 56100
        • Ikke rekrutterer endnu
        • Groupe Hospitalier Bretagne Sud - GHBS - Lorient
        • Kontakt:
    • Moselle
    • Pays de la Loire Region
      • Saint-Priest-en-Jarez, Pays de la Loire Region, Frankrig, 42270
    • Pyrénées Atlantiques
      • Pau, Pyrénées Atlantiques, Frankrig, 64000
        • Ikke rekrutterer endnu
        • Centre Hospitalier de Pau
        • Kontakt:
    • Seine-maritime
      • Montivilliers, Seine-maritime, Frankrig, 76290
        • Ikke rekrutterer endnu
        • Hôpital Jacques Monod - GH du Havre
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patient with endometriosis for whom an Endotest is prescribed

Beskrivelse

Inclusion Criteria:

  • Women with a prescription for Endotest
  • Women aged 18 to 43
  • Who have dated and signed the consent form
  • Affiliated with the French healthcare system or covered by health insurance abroad

Exclusion Criteria:

  • Contraindications for the use of Endotest:

    1. Current pregnancy;
    2. Medical history of cancer or HIV infection;
    3. Active infection at the time of saliva collection;
  • Significant difficulty reading and understanding the language of the country in which the participant is located.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Endometriosis cohort performing Ziwig ENDOTEST®
Andet: Questionnaire
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
Tidsramme: Day 1, 6 months and 12 months.

Endometriosis-specific quality of life score on the EHP-5 + 6 questionnaire (Endometriosis Health Profile - 11 items).

Score goes from 0 to 44. Higher the score is, worse the outcome is.
Day 1, 6 months and 12 months.
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
Tidsramme: Day 1, 6 months and 12 months
Score for each of the 8 dimensions of quality of life on the RAND-36 questionnaire (declined version of the 36-Item Short Form Survey (SF-36)) Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is.
Day 1, 6 months and 12 months
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
Tidsramme: 6 months

Factors associated with the level of endometriosis-specific quality of life (EHP-5+6 (Endometriosis Health Profile - 11 items)) at 6 months.

Score goes from 0 to 44. Higher the score is, worse the outcome is.
6 months
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
Tidsramme: 6 months

Factors associated with the level of each of the 8 dimensions of general quality of life (RAND-36 (declined version of the 36-Item Short Form Survey (SF-36)) at 6 months.

Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Describe the impact of Endotest on adaptation strategies.
Tidsramme: 6 months
Brief-COPE score (Brief Coping Orientation to Problems Experienced) Score goes from 1 to 4 for the 3 subscales (Problem Focussed, Emotion Focussed, Avoidant) There is no direct correlation between higher/lower scores and better/worse outcomes
6 months
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
Tidsramme: Through study completion, an average of 1 year
Number of patients starting an assisted reproductive technology (ART) treatment programme
Through study completion, an average of 1 year
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
Tidsramme: Through study completion, an average of 1 year
Number of patients for whom the ART treatment plan is amended (e.g. switching from intrauterine insemination to IVF, surgery)
Through study completion, an average of 1 year
Describe the impact of Endotest's results immediately following the announcement.
Tidsramme: 1 month
Personalised questionnaire on immediate emotional reactions
1 month
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
Tidsramme: Through study completion, an average of 1 year
Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.).
Through study completion, an average of 1 year
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
Tidsramme: Through study completion, an average of 1 year
Initiation or modification of treatments (hormonal, pain relievers, etc.).
Through study completion, an average of 1 year
To assess the impact of Endotest on anxiety levels.
Tidsramme: 1 month
Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is
1 month
Compare the care provided to patients with a positive Endotest result across participating countries.
Tidsramme: Through study completion, an average of 1 year
Type of coverage and waiting period
Through study completion, an average of 1 year
Compare pelvic sensitivity based on Endotest results
Tidsramme: Day 1 and 12 months
Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is.
Day 1 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ZIWIG

Samarbejdspartnere

Monitoring Force Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2026

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

31. juli 2029

Datoer for studieregistrering

Først indsendt

8. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025ZW03
  • 2026-A00166-45 (Anden identifikator: ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Endometriose (diagnose)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner